SpyGlass® Direct Visualization System

The SpyGlass Direct Visualization System is an integrated product platform that combines capital components and consumable devices and is designed to provide a direct intraluminal view of the biliary duct system and direct therapeutic devices.

HEALTH CARE PROFESSIONALS

Overview

Prescriptive Information

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The SpyGlass Direct Visualization System is the latest advancement in intraductal visualization during a cholangioscopy. The SpyGlass System is the first single operator, intraductal system that allows for not only optical viewing, but also optically-guided biopsies and has been shown to be compatible with electrohydraulic lithotripsy (EHL) and holmium laser to fragment stones.*

The SpyGlass System is designed to allow the physician the ability to directly see the site of interest, whether it be a stricture, stones or other area of concern, vs. traditional visualization techniques such as x-ray.

The SpyGlass System consumable devices include:

SpyGlass Fiber Optic Probe

This 6,000 pixel fiber optic probe enters the biliary anatomy through the SpyScope® Access and Delivery Catheter. It is designed to acquire and transmit endoscopic images and conduct light into the biliary anatomy.

70 degree field of view permits wide-ranging view of the anatomy
231 cm long
Fiber optic bundle surrounded by light fibers
Multiple use device that may be reprocessed after each use

SpyScope® Access & Delivery Catheter

The SpyScope Access & Delivery Catheter is a single-use, single-operator controlled, 10 Fr diameter, 230 cm length device designed to provide a pathway into the biliary anatomy for diagnostic and therapeutic devices.

Four lumen catheter includes:
- One optic channel
- One 1.2 mm accessory channel
- Two independent irrigation channels
Tip of catheter has 4-way steering capabilities to help with navigation and access into all 4 biliary quadrants

SpyBite® Biopsy Forceps

Using the SpyBite Biopsy Forceps with the SpyGlass Direct Visualization System is designed to allow the physician to directly see the area of interest to take targeted, optically-guided biopsies.

1.2 mm minimum working channel required
286 cm working length
Jaw designed with central spike to aid in securing small tissue samples
Single use device

EHL Compatible

The SpyGlass System has been shown to be compatible with the Northgate® 1.9Fr Biliary Probe and the Northgate Autolith® Intracorporeal Electrohydraulic Lithotripsy iEHL Generator.*

Laser Compatible

The SpyGlass System has been shown to be compatible with the Lumenis® SlimLine™ 365 Micron Laser Probe (M0068408420) and the Lumenis VersaPulse® PowerSuite™ 20 Watt Holmium Laser Generator (M0068408220).***

The SpyGlass System capital components include:

Component Cart and Three-Joint Arm
Lightsource and Cable – 300 watt high intensity white light
Camera and Camera Head – Auto shutter camera with 1⁄4" CCD color image sensor
Ocular – optical coupler that interfaces with the Probe and Camera Head
Isolation Transformer
Power Cable Pack
Irrigation Pump
Sony® Monitor

* Data on file, Boston Scientific Corporation. **Northgate and Autolith are trademarks of Northgate Technologies, Inc.
***Lumenis, VersaPulse, PowerSuite, and SlimLine are trademarks of Lumenis, Ltd.

Sony is a trademark of Sony Corporation of America.

MPDB5000 8/08 v4

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